Preview

User

Not a user? Register with this site Forgot your password?

Regulatory Research and Medicine Evaluation

Advanced search

Editorial Policies

Aim and Scope

Regulatory Research and Medicine Evaluation is a scientific and practical publication intended for a wide range of specialists, both Russian and foreign, working in the field of medicines:

- developers and manufacturers of medicines;

- representatives of expert bodies and national competent authorities;

- experts involved in control, licensing, and state supervision of the medicines lifecycle;

- employees of research institutes, lecturers, postgraduates, and students of medical and pharmaceutical universities, doctors, and pharmacists.

The aim of the journal is to promote development of academic and practical pharmaceutics and medicine by publishing and providing information on the latest achievements in this field.

 

Scope of the journal:

- publication of scientific, practical, and methodological articles and materials regarding development, expert evaluation, quality assessment, registration, standardisation and clinical application of medicines;

- provision of a consistent scientific and practical approach to covering the topics of the medicines lifecycle;

- establishment and promotion of scientific cooperation among Russian and foreign researchers;

- contribution to the journal founder's scientific status and authority amongst the professional community;

- promotion of professional competence of pharmaceutical industry specialists and provision of fully open access for all the interested parties.

 

 

Section Policies

REVIEW
Checked Open Submissions Checked Indexed Checked Peer Reviewed
MAIN TOPIC: SPECTROSCOPIC METHODS USED IN MEDICINE EVALUATION
Checked Open Submissions Checked Indexed Checked Peer Reviewed
NOMENCLATURE AND CLASSIFICATION OF MEDICINES
Checked Open Submissions Checked Indexed Checked Peer Reviewed
PRECLINICAL STUDIES
Checked Open Submissions Checked Indexed Checked Peer Reviewed
RADIOPHARMACEUTICALS
Checked Open Submissions Checked Indexed Checked Peer Reviewed
INTERNATIONAL COOPERATION
Checked Open Submissions Checked Indexed Checked Peer Reviewed
CLINICAL PHARMACOLOGY
Checked Open Submissions Checked Indexed Checked Peer Reviewed
Registration of medicines under the EAEU procedure
Checked Open Submissions Checked Indexed Checked Peer Reviewed
RETRACTION
Unchecked Open Submissions Checked Indexed Unchecked Peer Reviewed
LEGAL ASPECTS OF MEDICINES EVALUATION AND REGISTRATION
Checked Open Submissions Checked Indexed Unchecked Peer Reviewed
Biopharmaceutical research in vitro
Checked Open Submissions Checked Indexed Checked Peer Reviewed
authoritative opinion
Unchecked Open Submissions Checked Indexed Unchecked Peer Reviewed
CLINICAL STUDIES
Checked Open Submissions Checked Indexed Checked Peer Reviewed
DISEASE DIAGNOSTICS
Checked Open Submissions Checked Indexed Checked Peer Reviewed
AUTHORITATIVE OPINION
Checked Open Submissions Checked Indexed Checked Peer Reviewed
REGULATION OF MEDICINES
Checked Open Submissions Checked Indexed Checked Peer Reviewed
SAFETY OF MEDICINAL PRODUCTS
Checked Open Submissions Checked Indexed Checked Peer Reviewed
QUALITY CONTROL OF MEDICINES
Checked Open Submissions Checked Indexed Checked Peer Reviewed
THANK YOU TO ALL OUR REVIEWERS
Checked Open Submissions Checked Indexed Checked Peer Reviewed
TOXICITY STUDIES
Checked Open Submissions Checked Indexed Checked Peer Reviewed
IN VIVO STUDIES
Checked Open Submissions Checked Indexed Checked Peer Reviewed
DEVELOPMENT OF PAEDIATRIC MEDICINAL PRODUCTS
Checked Open Submissions Checked Indexed Checked Peer Reviewed
TESTING PROCEDURES
Checked Open Submissions Checked Indexed Checked Peer Reviewed
STANDARDISATION OF MEDICINES
Checked Open Submissions Checked Indexed Checked Peer Reviewed
DEVELOPMENT AND VALIDATION OF ANALYTICAL PROCEDURES
Checked Open Submissions Checked Indexed Checked Peer Reviewed
GENE THERAPY DRUGS
Checked Open Submissions Checked Indexed Checked Peer Reviewed
ANTIBACTERIAL DRUGS
Checked Open Submissions Checked Indexed Checked Peer Reviewed
INSULINS
Checked Open Submissions Checked Indexed Checked Peer Reviewed
MAGNESIUM PREPARATIONS
Checked Open Submissions Checked Indexed Checked Peer Reviewed
NANOSYSTEMS FOR DRUG DELIVERY
Checked Open Submissions Checked Indexed Checked Peer Reviewed
EXCIPIENTS
Checked Open Submissions Checked Indexed Checked Peer Reviewed
HERBAL MEDICINAL PRODUCTS
Checked Open Submissions Checked Indexed Checked Peer Reviewed
INSTRUMENTAL METHODS
Checked Open Submissions Checked Indexed Checked Peer Reviewed
PHARMACOPOEIA
Checked Open Submissions Checked Indexed Checked Peer Reviewed
REFERENCE STANDARDS
Checked Open Submissions Checked Indexed Checked Peer Reviewed
QUALITY CONТROL AT THE PRODUCTION SITE
Checked Open Submissions Checked Indexed Checked Peer Reviewed
MICROBIOLOGICAL TESTING
Checked Open Submissions Checked Indexed Checked Peer Reviewed
CLINICAL TRIAL PROGRAMMES
Checked Open Submissions Checked Indexed Checked Peer Reviewed
PATHOGENESIS ISSUES
Checked Open Submissions Checked Indexed Checked Peer Reviewed
INNOVATIVE MEDICINAL PRODUCTS
Checked Open Submissions Checked Indexed Checked Peer Reviewed
GENERIC MEDICINES
Checked Open Submissions Checked Indexed Checked Peer Reviewed
BIOTECHNOLOGICAL MEDICINAL PRODUCTS
Checked Open Submissions Checked Indexed Checked Peer Reviewed
PHARMACY COMPOUNDING
Checked Open Submissions Checked Indexed Checked Peer Reviewed
RADIOPHARMACEUTICALS
Checked Open Submissions Checked Indexed Checked Peer Reviewed
EXPERT OPINION
Checked Open Submissions Checked Indexed Checked Peer Reviewed
PHARMACEUTICAL TERMINOLOGY
Checked Open Submissions Checked Indexed Checked Peer Reviewed
COMPOSITION AND PHARMACOLOGICAL PROPERTIES
Checked Open Submissions Checked Indexed Checked Peer Reviewed
PHARMACEUTICAL MANUFACTURING
Checked Open Submissions Checked Indexed Checked Peer Reviewed
QUALITY CONTROL
Checked Open Submissions Checked Indexed Checked Peer Reviewed
CLINICAL TRIAL PROGRAMMES
Checked Open Submissions Checked Indexed Checked Peer Reviewed
REGULATORY PRACTICE AND RECOMMENDATIONS
Checked Open Submissions Checked Indexed Checked Peer Reviewed
SAFETY OF MEDICINES
Checked Open Submissions Checked Indexed Checked Peer Reviewed
BIOANALYTICAL METHODS
Checked Open Submissions Checked Indexed Checked Peer Reviewed
Main topic: PHARMACY COMPOUNDING: TASKS, PROBLEMS, SOLUTIONS
Checked Open Submissions Checked Indexed Checked Peer Reviewed
QUALITY CONTROL OF MEDICINES
Checked Open Submissions Checked Indexed Checked Peer Reviewed
DEVELOPMENT AND VALIDATION OF RESEARCH METHODS
Checked Open Submissions Checked Indexed Checked Peer Reviewed
 

Publication Frequency

Journal publication schedule

Volume

Issue number

Month of publication

Date of online version publication* 

15

No. 1

February

End of February

No. 2

April

End of April

No. 3

June

End of June

No. 4

August

End of August

No. 5

October

End of October

No. 6

December

End of December

*Scheduled publication dates are subject to change.

 

 

Open Access Policy

This is an open access journal. All articles are made freely available to readers immediatly upon publication.

Our open access policy is in accordance with the Budapest Open Access Initiative (BOAI) definition - it means that articles have free availability on the public internet, permitting any users to read, download, copy, distribute, print, search, or link to the full texts of these articles, crawl them for indexing, pass them as data to software, or use them for any other lawful purpose, without financial, legal, or technical barriers other than those inseparable from gaining access to the internet itself.

For more information please read BOAI statement.

 

Peer-Review

When working with manuscripts, communicating with reviewers, and managing the peer-review process at Regulatory Research and Medicine Evaluation, the editorial staff follow the Ethical Guidelines for Peer Reviewers by the Committee on Publication Ethics (COPE).

Peer-review type

At Regulatory Research and Medicine Evaluation, all submitted manuscripts are subject to mandatory double-blind peer review. This means that both the submission’s author and its reviewer are not informed of each other’s names or positions, and all communication between them is mediated by an editor of the journal. The editors send each manuscript to at least two reviewers.

Methodology articles, guidelines, and informational materials (regulatory decisions, news, etc.) are not subject to mandatory peer review.

Peer-review duration

At Regulatory Research and Medicine Evaluation, an average peer-review procedure takes 1–6 months. This period includes initial consideration of the manuscript, selection of reviewers, preparation of reviews, follow-up revision by the authors, follow-up review by the reviewers, and involvement of additional experts.

Peer-review process

Reviewers are selected by a scientific editor, the executive secretary, or the editor-in-chief of Regulatory Research and Medicine Evaluation.

A minimum of two reviewers are assigned to each manuscript. If these two reviewers disagree on the manuscript, the editorial staff may consult a third reviewer.

Negative reviews do not necessarily mean rejection by the journal. Manuscripts with negative reviews are presented to the Editorial Board for consideration, along with the corresponding reviewers’ and editors’ comments. The final decision to publish the manuscript is made by the editor-in-chief.

Depending on the review outcome, the scientific editor will inform the author of one of the following decisions:

Acceptance for publication

In this case, the manuscript will proceed to the editing stage and will be published in a future issue of Regulatory Research and Medicine Evaluation. The author will be informed of the publication date.

Acceptance for publication after revision according to the reviewers’ comments

In this case, the author will be advised to revise the manuscript according to the reviewers’ comments. If the author makes changes according to the reviewers’ comments or presents a reasoned refusal to change the manuscript, the manuscript will be accepted for publication.

Acceptance for publication after revision according to the reviewers’ comments and another round of peer review

In this case, the author will be recommended to revise the manuscript according to the reviewers’ comments. The manuscript will then be sent for a second round of peer review. The author will be informed of the final decision on the manuscript within 30 days.

Rejection

In this case, the manuscript will be rejected, and the author will be informed of the reasons for rejection. Generally, a rejection does not bar authors from submitting other manuscripts to Regulatory Research and Medicine Evaluation. However, if the rejection is due to serious misconduct, the editor-in-chief may choose to blacklist the authors. As a result, the editorial staff will not consider any further submissions by them.

At Regulatory Research and Medicine Evaluation, the peer-review process involves three rounds of review. Therefore, if recommended to revise the manuscript according to the reviewers’ comments, the author has two attempts to revise the manuscript or to present a reasoned refusal to change it. If a reviewer is not satisfied after the third round of review, the author will be suggested to consider submitting the manuscript to another journal or resubmitting a revised version in 6 months.

The editorial staff should be informed if the author is unwilling or unable to revise the manuscript. Upon notification, the editorial staff will stop working on the manuscript. If the author fails to submit a revised version of the manuscript within 1 month of receiving the reviewers’ comments, the editorial staff will stop working on the manuscript even without notification from the author, as the revision period will have expired. The decision will be communicated to the author by e-mail.

If the author has a conflicting interest with a potential reviewer, the author should disclose this to the editor. If necessary, the journal’s editorial staff will appoint another peer reviewer.

A conflict of interest between an author and a reviewer may arise during peer review. In such case, the editor has the right to select another reviewer for the manuscript and to appeal to the editor-in-chief for reconciliation.

The editor-in-chief, deputy editors-in-chief, the executive secretary, and Editorial Board members may publish their articles in Regulatory Research and Medicine Evaluation, provided that they do not abuse their authority. The manuscripts submitted by the authors affiliated with the journal will be assigned for double-blind peer review exclusively to external reviewers. Disagreements and conflicts will be resolved exclusively by external experts. If there are conflicting views regarding a manuscript submitted by the editor-in-chief, the final decision on its publication will be made by the Editorial Board.

The articles submitted by the editor-in-chief, deputy editors-in-chief, and Editorial Board members should indicate the authors’ affiliation with Regulatory Research and Medicine Evaluation in the Disclosure section.

There are no exceptions to peer review based on the status of the author.

Copies of reviews are kept on file in the editorial office for at least 5 years.

Pool of reviewers

All the submitted manuscripts are reviewed by external reviewers experienced in the relevant field who have published works on the topic of the manuscript under review within the last 3 years.

If the topic of the manuscript is very narrow and/or its author declares a potential conflict of interest with external reviewers, the editors may involve Editorial Board members in the peer-review process.

Reviewer selection principles and measures taken by the editorial staff to ensure high-quality review

The editorial staff ensure timely rotation of the reviewers working for the journal and regularly invite recognised experts in pharmaceutical formulation and manufacturing; pharmaceutical chemistry and pharmacognosy; pharmaceutical management; pharmacology, clinical pharmacology to join the pool of reviewers for Regulatory Research and Medicine Evaluation.

The reviewers are invited to work for Regulatory Research and Medicine Evaluation on the recommendation of the editor-in-chief, deputy editors-in-chief, Editorial Board members, and scientific editors.

The scientific editors routinely monitor the Scopus, Web of Science, and RISC databases for publications related to the subject area of the journal and send collaboration invitations to the authors of relevant publications.

The first review prepared by a reviewer is evaluated using the following Review Quality Instrument:

  1. Did the reviewer discuss the importance of the research question?
  2. Did the reviewer discuss the originality of the manuscript?
  3. Did the reviewer clearly identify the strengths and weaknesses of the research (study design, data collection, and data analysis)?
  4. Did the reviewer make specific and useful comments on the writing, organisation, tables, and figures in the manuscript?
  5. Were the comments of the reviewer constructive?
  6. Did the reviewer supply appropriate evidence using examples from the article to substantiate their comments?
  7. Did the reviewer comment on the author’s interpretation of the results?
  8. How would you rate the overall review quality?

The score range for each question is 1 to 5, where 1 is the lowest score and 5 is the highest score.

If the editors of the journal are not happy with a review, they stop working with the reviewer.

The editors are entitled to use the above instrument to evaluate the quality of an unrestricted number of reviews by any reviewer working for Regulatory Research and Medicine Evaluation.

Reviewer engagement

At Regulatory Research and Medicine Evaluation, the editors consider peer review one of the most important processes for the journal; they value the expertise and time of the reviewers involved.

The reviewers are entitled to priority publication and translation of accepted manuscripts into English.

The editors submit texts of reviews and information about the reviewers to the Scientific Electronic Library (eLIBRARY.RU), which publishes these reviews and information on access-controlled pages for library users. The results of reviews are stored on the personal profiles of the reviewers and considered when assessing their performance as researchers.

Confidentiality

At Regulatory Research and Medicine Evaluation, the editors keep the reviewers’ and the authors’ personal data confidential.

The manuscripts submitted to the journal are treated as confidential documents, and the editorial staff expect that the reviewers will not share or discuss them with third parties, unless authorised by the editorial staff. Only with the consent of their editor may the reviewers involve third parties in the peer-review process.

Reviewer Responsibilities

By agreeing to review a manuscript for Regulatory Research and Medicine Evaluation, the expert commits to following the journal’s policies, ethical requirements, and professional standards for evaluating manuscripts and preparing reviews.

The reviewer should strive to ensure the high quality of the materials published in Regulatory Research and Medicine Evaluation, just like the editors of the journal. Therefore, the reviewer should agree to review only if they have sufficient expertise in the subject and enough time to carry out a thorough and comprehensive review.

The reviewer is obliged to inform the scientific editor of having a conflicting interest (personal, financial, intellectual, professional, political, or religious). When in doubt, the reviewer should discuss the potential conflict of interest with the scientific editor.

The reviewer may refuse to work on the manuscript at any stage of the peer-review process. In this case, the reviewer should inform the editorial staff.

The reviewer should refrain from reviewing if:

  • They are in a superior–subordinate position or hold joint grants with the author;
  • They do not intend to review the manuscript, but want to gain sight of it;
  • They are going to publish an article on a similar topic; or
  • They are reviewing a manuscript on a similar topic.

The reviewer should inform the editor of their consent to review the manuscript, and they should complete the review within the time limits specified by the editor. When unable to review, they should recommend an alternative reviewer to the editor.

The reviewer cannot use their status for personal purposes or impose references to their own publications on the authors.

All the materials that the reviewer receives from the editor are strictly confidential. The reviewer should not share these materials with third parties or involve other specialists in the review of a manuscript, except if authorised by the editorial staff.

Recommendations for reviewers

For the reviewer’s convenience, the editors recommend using the Standard Review Form. This form lists the questions that the editors need the reviewer to answer in order to decide on the manuscript.

The editors of the journal ask the reviewer to pay particular attention to the section on the shortcomings of the work and recommendations for its correction.

The reviewer may provide comments in a free format.

Review content and structure

This section follows the recommendations of the National Electronic Information Consortium (NEICON). Regulatory Research and Medicine Evaluation is allowed to use these methodological recommendations in its review policy.

10 criteria for manuscript evaluation:

– originality;

– logical rigour;

– statistical rigour;

– clarity and conciseness of writing style;

– theoretical significance;

– reliability of the results;

– pertinence to current research in the discipline;

– reproducibility of the results;

– coverage of significant existing literature;

– applicability of the results.

In addition to the Standard Review Form, the editors of the journal recommend using the following review structure.

Comments for editors. The Conflict of Interest section should describe actual or potential conflicts of interest related to the content of the manuscript or its authors, which may lead to a biased conclusion. The Confidential Comments section is intended for comments that will not be sent to the author. It should include the reviewer’s conclusion on the manuscript, assumptions, concerns about potential ethical issues, recommendations, and comments (e.g., the reviewer may advise the editor to request additional information from the author). The Proposed Decision section should contain a brief recommendation on manuscript publication (i.e., “accept for publication”, “accept for publication after minor revision”, “accept for publication after major revision”, “reject”, “reject and invite the author to resubmit the manuscript for reconsideration”).

Comments for authors. The Introduction section should contain the main conclusions and describe the value of the article to readers. The Main Comments section is intended for comments on the relevance of the article to the aims and objectives of Regulatory Research and Medicine Evaluation and on the level of credibility and ethical conduct of the research. Comments on individual sections (i.e., the Abstract, Introduction, Materials and Methods, Results, and Discussion sections), pages, paragraphs, or lines of the manuscript are given in the Specific Comments section. The Recommendations for the Author section should include the reviewer’s suggestions for improving the manuscript and, possibly, future research. The Concluding Comments section should briefly describe the strengths and weaknesses of the manuscript without giving any additional recommendations.

Manuscript evaluation criteria

Relevance to the journal. The reviewer should not waste their time reviewing irrelevant manuscripts, regardless of the quality of such manuscripts. Therefore, the first step is to determine whether the manuscript to be reviewed is pertinent to the subject area of Regulatory Research and Medicine Evaluation and relevant to the interests of the journal’s target audience.

Soundness. Does the work meet the necessary requirements for the study design, methods, structure, content, and depth of analysis? Does the author adhere to the principle of impartiality? Are the results reproducible? Is the study sample adequate? Has the author analysed the sample in sufficient detail to be able to make generalisations from the study findings?

Novelty. Has the research contributed anything new to the relevant subject area?

Ethics. Does the study meet the requirements for originality? Has the institutional review board approved the study (if applicable)? Does the study meet the requirements for impartiality in terms of conflicting interests? Regardless of its perceived significance, the manuscript cannot be accepted if it is a redundant publication, contains plagiarism, or violates the basic ethical principles of scientific research (justice, beneficence, and respect for persons).

Evaluation of manuscript elements. The editors of the journal recommend using the following questions to speed up the process of preparing an expert opinion and provide the most complete information about the article to the editor and the author.

Title. Does the title accurately reflect the content of the manuscript? Will the title attract readers’ attention?

Abstract. Does the abstract appropriately present the content of the manuscript? Is the abstract structured? Does the abstract describe the aim, methods, results, and significance of the work? Are there any discrepancies between the abstract and the sections of the manuscript? Is it possible to understand the abstract without reading the manuscript?

Introduction. Is the introduction short? Are the aim and the research question stated clearly? Has the author justified the relevance and significance of the work via a literature review? If so, does the introduction meet the requirements for length? Has the author defined the terms used in the manuscript? If the manuscript is submitted to the Original Research section, does it have a clearly stated hypothesis?

Literature review. How comprehensive and complete is the literature review?

Methods. Are the methods clear? Would another researcher be able to reproduce the study using the proposed methods? Have the authors justified their choice of methods (e.g. imaging techniques, analytical tools, or statistical methods)? If the authors pose a hypothesis, have they developed methods that can reasonably test it? How is the study design presented? How does the analysis of study data help achieve the aim of the work?

Results. Are the results clear? Does the order of result presentation match the order of method description? Are the results as expected? Are there results not preceded by an appropriate description in the Methods section? How accurate is the presentation of the results?

Discussion. Is the discussion short? If not, how can it be shortened? If a hypothesis is stated, is there a report on whether it has been confirmed or refuted? If the research has not confirmed the hypothesis, have the authors answered the research question? Are the authors’ conclusions consistent with the results obtained? If the results are unexpected, have the authors analysed them appropriately? What potential contribution does the study make to the field of research and science?

Conclusions. Have the authors acknowledged the limitations of their work? Are there any additional limitations that should be pointed out? What is the authors’ opinion on the limitations? What is the authors’ opinion on the directions for future research?

References. Does the list of references conform to the requirements of the journal? Are there any bibliographical errors in the list of references? Are the references cited correctly in the text? Are there any additional important publications that should be referenced? Are there too many references? Are the referenced publications still relevant?

Tables. If the article contains tables, do they present the results correctly? Should one or more tables be added? Are the data tabulated in a way that facilitates their understanding?

Figures. Are the figures suitable for addressing the research question? Would different figures better illustrate the findings? Do the figures and graphs adequately illustrate important findings? Should changes be made to the figures and graphs for a more accurate and clear presentation of the findings? Can the figures and graphs be understood from the captions without reading the manuscript?

Disclosure. Is the information on funding and conflicts of interest clearly disclosed?

Final decision of the reviewer

The editorial staff of the journal recommend using the following reasoning for the final decision of the reviewer.

Acceptance for publication. The reviewer understands that the manuscript is ready for publication in its current version. The work is sound, ethical, and significant for the scientific community. It complements previously published works. Its writing style is clear and concise.

Acceptance after minor revision. There are a few non-critical comments about the article that need to be addressed. These comments may point out poor writing style; lack of clarity; insufficiently developed structure; errors in references; or duplication of information in the text, figures, and tables. The article may be accepted for publication after revision and re-evaluation.

Acceptance after major revision and another round of peer review. The article has serious flaws and errors affecting the validity of the obtained results. Such flaws and errors may include ethical issues, a poor research design, gaps in the description of research methods, poorly presented or misinterpreted results, an incomplete description of study limitations, contradictory conclusions (or conclusions refuted by the author’s own statements), a lack of references to important publications, or unclear tables and figures that require serious revision. After another round of peer review, the article may be accepted, rejected, or sent for additional review. This decision often requires soliciting additional information from the author.

Rejection. The work does not correspond to the aims and objectives of Regulatory Research and Medicine Evaluation because there are irremediable flaws or serious ethical problems, for example, the authors have not obtained consent to publication of data (if required); the authors use unethical research methods; or the authors use discredited or flawed research methods (e.g., by ignoring a process that seriously affects the results). If this is the case, the author should not submit a revised version without a specific request. The reviewer should provide detailed comments justifying their decision as such comments may help the author to significantly improve their work.

Rejection and invitation to resubmit the article for consideration. The topic or the research question is interesting, but the author uses incorrect or unreliable methods, therefore, the data obtained are unreliable. This decision may also be made if the article requires multiple changes or if it is not possible to obtain the requested additional information from the author. The authors are encouraged to conduct the study taking into account the recommendations and submit new results for consideration.

Editing of reviews

The reviews should be written in a friendly tone and correct Russian language. The reviewers must avoid derogatory personal comments, insults to the author, and unjustified criticisms of the study aspects, the language and style of the manuscript, etc.

The editorial staff of the journal attempt to send the authors unedited reviews. However, the editorial staff may edit some of the reviews without sacrificing the meaning (for example, to combine comments on the same issue received from several reviewers or to transfer confidential comments from the section intended for the author).

If a review has many mistakes or an unacceptable tone, the editorial staff of the journal have the right to send it back to the reviewer for revision.

Acknowledgement of reviewers

To acknowledge participation in the peer review process at Regulatory Research and Medicine Evaluation, the last issue of the year features an annual listing of the contributing reviewers.

 

Indexation

The journal Regulatory Research and Medicine Evaluation is included into the List of leading peer-reviewed scientific journals and publications recommended by the Higher Attestation Commission of the Russian Federation for publishing main results of the dissertation research for the candidate or doctor of sciences degree.

The articles published in Regulatory Research and Medicine Evaluation are indexed by several systems:

 

Publication Ethics

Authorship, contributions, acknowledgements

Authorship

At Regulatory Research and Medicine Evaluation, we adhere to the following authorship criteria (developed and described in the ICMJE guidelines):

  • Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work;
  • Drafting the work or reviewing it critically for important intellectual content;
  • Final approval of the version to be published;
  • Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Apart from being accountable for the parts of the study performed on their own, an author should be able to identify specific parts of the work the other co-authors are responsible for.

In addition, the authors should have confidence in the integrity of the contributions of their co-authors. All those designated as authors should meet all four criteria for authorship, and all who meet the four criteria should be identified as authors.

Those who do not meet all four criteria should be mentioned in the Acknowledgements section.

Author and non-author contributions

The Acknowledgements section can be used to thank contributors to the research that do not fulfil the criteria for authorship, for example, those who supported the study, played a supervisory role, assisted with data collection, coordinated the study, etc.

To correctly identify contributions, the authors of Regulatory Research and Medicine Evaluation may use one of the schemes recommended by the COPE:

Responsibility

At Regulatory Research and Medicine Evaluation, it is the responsibility of the editors to ensure that the authorship and author contribution standards are met.

The authors submitting a manuscript are obliged to provide transparent and correct information about themselves and persons who made significant contributions to their study.

If a manuscript is submitted to the journal by the Editor-in-Chief, Deputy Editor-in-Chief, or a member of the Editorial Board, the manuscript is sent out for external peer review without exception.

To correctly identify contributions, we recommend the following resources:

Authorship declaration

The editorial staff of Regulatory Research and Medicine Evaluation require that the authors should supplement their submissions with an authorship declaration signed by all co-authors.

By signing the declaration, the authors guarantee that:

  • Each author signing the declaration meets the authorship criteria as outlined in the policy section on publication ethics;
  • All individuals who participated in the study but are not the authors are specified in the Acknowledgements section;
  • Each author’s contribution is described (this information will be published in Regulatory Research and Medicine Evaluation);
  • The authors take responsibility for the accuracy of the information provided.

Upon receipt of a manuscript, the editors will verify that the authorship information and all the required documents are in place. In the absence of the authorship declaration or signatures from all the authors, the manuscript will not be accepted for consideration.

Disputes

In the case an authorship dispute arises, the work on the article will be terminated regardless of the stage of its consideration, reviewing, editing, or preparation for printing.

All the co-authors will be informed about the authorship dispute via e-mail.

The editors of Regulatory Research and Medicine Evaluation are entitled to set a precise deadline for the authors to provide clarification on the issues specified by the editors. Upon expiry of this period, the publication process is discontinued for this manuscript with an appropriate explanation. If an article has been published as an Online First version, the clarification on withdrawal of the article from publication will be placed in the public domain.

In the case of a dispute regarding a published article, the editors of the journal will publish a correction, refutation, or retraction notice, explaining the reason for the changes made to the published document.

If it is necessary to add or remove a co-author before or after publication, the Editorial Office of Regulatory Research and Medicine Evaluation act in accordance with the COPE guidelines:

To prevent co-authorship fraud, the editors of Regulatory Research and Medicine Evaluation use COPE flowcharts and note the following when working with submissions:

  • Industry funded research with no authors from the sponsor company, as these may require the editors to take a closer look at the authors’ contributions and, if necessary, to request explanations from the corresponding author;
  • Names on the author list known to be from an unrelated research area, as this may indicate guest authorship;
  • Unspecified roles in the Acknowledgements section;
  • Unfeasibly long or short author lists uncharacteristic of the research area or article type;
  • Questionable roles of contributors (for example, it appears that no one drafted the manuscript or analysed the data);
  • Plagiarism check results indicating borrowing from a thesis, with the original author of this thesis not on the author list or not acknowledged;
  • Several articles published on a similar topic by other author groups;
  • Authorship changes during revision stages without notifying the editorial staff;
  • Impossibly prolific authors holding positions that do not provide for such publication activity (department head, institute director, etc.);
  • Corresponding authors unable to respond to reviewers’ comments.

The editorial staff of the journal expect that organisations affiliated with the authors will readily participate in the resolution of authorship disputes.

Complaints and appeals

At Regulatory Research and Medicine Evaluation, the Editorial Office carefully considers complaints about the behaviour of editors and peer reviewers, which may relate to issues such as a breach of confidentiality, an undisclosed conflict of interest, or a misuse of confidential information obtained during the peer-review process. The authors may also disagree with decisions regarding expressions of doubt on certain articles and complain about non-compliance with the editorial policies.

Complaints should be emailed to vedomosti@expmed.ru for consideration according to the standard procedure. Normally, complaint handling takes no more than 7 days. The editorial staff will inform the complainant of the decision, as well as of the corrective actions initiated and the deadlines for their implementation.

The editorial staff adhere to the COPE Guidelines for handling complaints in each of the following cases:

Ethical oversight

At Regulatory Research and Medicine Evaluation, we share the COPE’s view that publication ethics includes not only ensuring the integrity and reliability of published research but also ethical behaviour towards research subjects. Research subjects include vulnerable populations, laboratory animals, and human subjects (in applicable studies). Also, ethical oversight covers handling confidential data and ethical business/marketing practices.

Informed consent and consent for publication

At Regulatory Research and Medicine Evaluation, an informed consent/consent for publication form is required for every study in which one or several persons can be identified. Consent for publication is also required when a study mentions deceased people. Consent is required for the publication of clinical cases, photographs, x-rays, etc.

The authors are required to provide the Editorial Office  with a statement reporting that informed consent has been obtained from the patients or their representatives. The published article will inform that such consent has been obtained.

The informed consent should include the following:

  1. The patient should fill in their name and sign the form.
  2. If a patient is unable to do so, the relationship of the signer to the patient must be stated.
  3. If one person is signing for a family or a group of people, that person should attest that all the members of the family/group have been informed.
  4. It should be stated that the person or group of persons has no legal, mental, or physical impediment to consent to publication. If such impediments exist, they should be stated (minor age, incapacity, disability, death, etc.).
  5. The person taking informed consent must have the authority to obtain it.
  6. Forms should make it clear that, even if all the rules are followed, the journal cannot guarantee confidentiality.
  7. The patient should be informed that they may revoke consent at any time before the publication of the article.
  8. The form should indicate how the article will be distributed (in print, online).
  9. The form should indicate that the patient has seen the final version of the manuscript. If this is not the case, it should clearly indicate that the patient or their representative consented to publication without seeing the final version of the manuscript.

Vulnerable populations

Vulnerable populations include (but are not limited to) those who are incapable of protecting their own interests, and hence pregnant women, neonates, children, foetuses, prisoners, physically handicapped, mentally challenged, economically disadvantaged, institutionalised and very sick patients, etc., can all come under this group.

A study must be planned in vulnerable populations only if that population will benefit from this study.

One of the important points of concern in vulnerable populations is that some lack the ability to consent or understand. In that case, a legally acceptable representative should be involved in the decision. Special care should be taken in the studies involving children.

At Regulatory Research and Medicine Evaluation, the Editorial Office supports the COPE’s position statement on the publication of studies involving vulnerable groups and individuals.

The authors should obtain informed consent from the study participants to publish the results and notify the editorial staff of it.

Ethics of animal use in research

When conducting experimental research in animals, the authors are obliged to include information on compliance with institutional and national standards on the use of laboratory animals.

To present more accurate and correct information about research involving animals, the editorial staff recommend following the ARRIVE guidelines and the European Convention for the Protection of Vertebrate Animals Used for Experiments or Other Scientific Purposes. The use of these standards will improve the quality and reliability of published articles and allow other researchers to reproduce the results.

Ethics of research involving human subjects

At Regulatory Research and Medicine Evaluation, we rely on the principles of the Declaration of Helsinki of the World Medical Association (Ethical Principles for Medical Research Involving Human Subjects) and endeavour to ensure compliance with ethical and data collection standards for research involving human subjects. Before beginning a study, researchers should familiarise themselves with the informed consent principles of the Declaration of Helsinki and carry out the study in strict accordance with those principles as set forth below (Articles 25‒32 of the Declaration of Helsinki). When presenting the results of experimental research involving humans, the authors should indicate in the corresponding section of the article whether the procedures performed met the ethical standards described in the Declaration of Helsinki. If the study did not follow the Declaration, the authors should justify the approach chosen for the study and provide evidence that the Ethics Committee of the organisation where the study took place had approved the chosen approach.

“25. Participation by individuals capable of giving informed consent as subjects in medical research must be voluntary. Although, it may be appropriate to consult family members or community leaders, no individual capable of giving informed consent may be enrolled in a research study unless he/she freely agrees.

26. In medical research involving human subjects capable of giving informed consent, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, post-study provisions and any other relevant aspects of the study. The potential subject must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal. Special attention should be given to the specific information needs of individual potential subjects as well as to the methods used to deliver the information.

After ensuring that the potential subject has understood the information, the clinician or another appropriately qualified individual must then seek the potential subject’s freely-given informed consent, preferably in writing. If the consent cannot be expressed in writing, the non-written consent must be formally documented and witnessed.

All medical subjects should be given the option of being informed about the general outcome and results of the study.

27. When seeking informed consent for participation in a research study, the physician must be particularly cautious if the potential subject is in a dependent relationship with the physician or may consent under duress. In such situations, the informed consent must be sought by an appropriately qualified individual who is completely independent of this relationship.

28. For a potential research subject who is incapable of giving informed consent, the physician must seek informed consent from the legally authorised representative. These individuals must not be included in a research study that has no likelihood of benefit for them unless it is intended to promote the health of the group represented by the potential subject, the research cannot instead be performed with persons capable of providing informed consent, and the research entails only minimal risk and minimal burden.

29. When a potential research subject who is deemed incapable of giving informed consent is able to give assent to decisions about participation in research, the physician must seek that assent in addition to the consent of the legally authorised representative. The potential subject's dissent should be respected.

30. Research involving subjects who are physically or mentally incapable of giving consent, for example, unconscious patients, may be done only if the physical or mental condition that prevents giving informed consent is a necessary characteristic of the research group. In such circumstances the physician must seek informed consent from the legally authorised representative. If no such representative is available and if the research cannot be delayed, the study may proceed without informed consent provided that the specific reasons for involving subjects with a condition that renders them unable to give informed consent have been stated in the research protocol and the study has been approved by a research ethics committee. Consent to remain in the research must be obtained as soon as possible from the subject or a legally authorised representative.

31. The physician must fully inform the patient which aspects of their care are related to the research. The refusal of a patient to participate in a study or the patient's decision to withdraw from the study must never adversely affect the patient-physician relationship.

32. For medical research using identifiable human material or data, such as research on material or data contained in biobanks or similar repositories, physicians must seek informed consent for its collection, storage and/or reuse. There may be exceptional situations where consent would be impossible or impracticable to obtain for such research. In such situations, the research may be done only after consideration and approval of a research ethics committee”.

According to the Sex and Gender Equity in Research (SAGER) Guidelines, the title and abstract of an article should indicate what sex(es) the study findings apply to (if the study involved subjects of only one of the sexes). The Introduction section of the article should reference publications that demonstrate sex-related differences (e.g., higher prevalence of the disease in one of the sexes) or the absence of such differences. The authors should indicate how possible differences were accounted for in the design of their study, whether the authors ensured adequate representation of male and female study participants, whether the authors used sex-related inclusion/exclusion criteria, and whether there were specific recommendations based on sex (e.g. mandatory contraception). If necessary, when describing the results of the study, the authors should provide preclinical and clinical data disaggregated by sex and discuss the respective results. The authors should discuss the extent to which the findings can be generalised to both sexes. If there was no analysis by sex, a rationale should be given in the Discussion section.

Handling confidential data

The right to privacy of individuals or organisations involved in research is of paramount importance; such research should not be conducted without informed consent. The authors must take all necessary precautions to protect information about study participants. If necessary, the authors must take measures to minimise any potential physical and psychological harm to research participants.

Responsibilities of the management team of the journal, including the Editorial Board, the editors, the publisher, and the founder

Editorial Board recruitment

When forming the editorial board, the editorial board of the journal Regulatory Research and Medicine Evaluation is guided by the COPE principles.

The editor-in-chief is appointed by the journal founder for a 3-year term. The appointment may be terminated early upon a personal application of the editor-in-chief or by decision of the founder of the journal.

New candidates may be recommended by current members of the editorial board, reviewers, authors, as well as the candidates themselves by application.

A candidate for the editorial board shall send an application to the editor-in-chief, who makes the final decision on including the candidate in the editorial board.

Candidates shall accept the following conditions:

  • Priority is given to candidates with an academic degree (PhD, Doctor of Science) and scientific publications for past 3 years relevant to the journal scope.
  • The term is 3 years with renewal possibility. It may be terminated early (with 10-day notice to the editor-in-chief).
  • The candidate must disclose all potential and actual conflicts of interest (e.g. any activity in publishing scientific journals and books, membership in the editorial boards/councils of other journals) and any conflicts of interest that may arise after joining the editorial board.
  • Participation in multiple editorial boards/councils is permitted only if the candidate has different decision-making powers, or article commissioning responsibility in each editorial board.

Responsibilities of Editorial Board members

  • To publish 1 article per year to support the journal.
  • To review incoming manuscripts in their area of expertise and in the absence of external reviewers. Each member of the Editorial Board will receive a maximum of 2 manuscripts per year for review. Reviewing should be carried out in accordance with the approved Reviewing Policy of the journal.
  • To select reviewers for incoming manuscripts at the request of the Executive Secretary and to control the peer-review process.
  • To make decisions on the possibility of publishing articles after all rounds of peer review. The decisions will be passed to the Editor-in-Chief, who will make the final decision on the possibility of publication.
  • To invite authors and peer reviewers to work with the journal.

A member may be excluded from the Editorial Board for the following reasons:

  • violations of the publication ethics, such as concealing a conflict of interest, withholding information, and using the membership for personal purposes;
  • failure to fulfil the assigned duties within a year without a valid reason and without agreement with the Editor-in-Chief;
  • voluntary resignation.

Privileges of Editorial Board members

  • Manuscripts submitted by the Editorial Board members will be considered on a priority basis.
  • One article per year will be translated into English by the editorial staff of the journal.
  • A member of the Editorial Board may participate in events organised by the journal and the founding organisation free of charge.
  • A member of the Editorial Board may act as a guest editor for special issues of the journal.
  • Information about the Editorial Board members will be placed on the website of the journal with the necessary links to profiles in databases, affiliations, and other necessary data.

The possibility of including potential candidates in the Editorial Board is considered at regular meetings of the Editorial Board.

The final decision on the inclusion of a potential candidate in the Editorial Board is made by the Editor-in-Chief.

Responsibilities of scientific editors

At Regulatory Research and Medicine Evaluation, the scientific editors are personally responsible for the decisions to publish articles. The final decision on publication is made by the Editor-in-Chief of the journal.

When reviewing manuscripts and deciding on their publication, the scientific editors of the journal are guided by the journal policies.

A scientific editor may discuss the manuscript and reviewers' comments with other editors and peer reviewers, provided that these discussions are justified and legitimate and the discussed materials are not used for personal purposes.

The scientific editors of the journal are obliged to evaluate the content of manuscripts regardless of the race, sex, orientation, religious views, background, citizenship, or political preferences of the authors.

The scientific editors of the journal should ensure confidentiality and should not disclose information about submitted manuscripts to third parties (except for other editors of the journal, peer reviewers, the publisher, and the founder).

The scientific editors of the journal should inform the Editor-in-Chief about all conflict situations, critical errors, or accusations of authors or peer reviewers in violations of publication ethics in order to take the necessary actions in such cases, such as making amendments, publishing retractions, withdrawing articles, and expressing doubts.

The scientific editors of the journal should take part in the investigation of any ethical violations related to the manuscripts under review and published articles and make every effort to resolve conflicts as soon as possible. If necessary, the scientific editors will liaise with the author's organisation to conduct a more in-depth investigation.

Responsibilities of the Publisher

The Publisher is responsible for complying with all current guidelines and requirements to maintain the integrity of scientific materials published in the journal.

The Publisher is responsible to implement industry standards in the editorial work in order to improve the ethical performance of Regulatory Research and Medicine Evaluation.

The Publisher is obliged to provide comprehensive legal support to the editorial staff of the journal if necessary.

Responsibilities of the Founder

The Founder of Regulatory Research and Medicine Evaluation adheres to the principle of editorial independence; the Founder does not interfere in the editorial process.

The Founder of the journal can recommend potential candidates for the Editorial Board, peer reviewers, and authors, but the final decision on the possibility of working with them is made exclusively by the Editor-in-Chief.

The Founder of the journal supports the need to ensure geographic diversity among the members of the Editorial Board/Council, peer reviewers, and authors.

The Founder does not place financial and political gain above the quality of the journal. The journal decides on the publication of manuscripts based on their quality and interest to the target audience.

The Founder does not interfere in the editorial process of the journal, but if necessary and at the request of the editors the Founder can contribute to investigating violations of publication ethics and send official requests to scientific and educational organisations, as well as other publishers.

 

Publication Fee

Publication of articles in the Regulatory Research and Medicine Evaluation is free of charge for all the authors.

The journal doesn't have any article processing charges.

 

Disclosure and Conflicts of Interest

This section was prepared according to the WAME recommendations.

A conflict of interest exists when an individual holds contradictory or competing interests that could bias editorial decisions on a manuscript as well as the interpretation of data in it. Conflicts of interest may be potential or perceived, or they may be actual. The impartiality of opinion may be influenced by personal, political, financial, scientific, or religious considerations.

Conflicts of interest may include:

  • Financial ties. This conflict is present when a participant in the publication process has received or expects to receive money (or other financial benefits, such as patents or stocks), gifts, or services that may influence their work on a specific publication. Examples of financial ties include but are not limited to payment for research, fees for advice, and honoraria for public speaking.
  • Personal relationships. This conflict arises from personal relationships with family members, friends, competitors, and former colleagues.
  • Political or religious beliefs. Commitment to a particular religion or political party may pose a conflict of interest for a publication on religious or political issues.
  • Institutional affiliations. This conflict of interest arises when a participant in the publication process is directly affiliated with an institution having an interest in the publication.

At Regulatory Research and Medicine Evaluation, the editors may ask the authors additional questions or request lacking information (if necessary).

Conflicts of interest may involve the authors, peer reviewers, and editors. The following policy statements are based on the ICMJE recommendations.

Responsibility of the authors to disclose conflicts of interest

The authors submitting a manuscript of any type or format are responsible for disclosing all relationships and activities that might bias or be seen to bias their work.

The authors must inform the editor of all actual or potential conflicts of interest by providing details in the appropriate section of the article.

If there are no conflicts of interest, the authors should also report this. For example: “The authors declare no conflict of interest.”

Responsibility of the reviewers to disclose conflicts of interest

The peer reviewers must inform the editors of any conflict of interest that may influence their assessment of a particular manuscript. If there are grounds for bias, the reviewers should recuse themselves from reviewing.

The reviewers should not use information from manuscripts under review for their own advantage prior to publication of the manuscripts.

Responsibility of the editors to disclose conflicts of interest

The editors involved in making final editorial decisions should refrain from making decisions on a manuscript if they have a conflict of interest or if their actions may give rise to potential conflicts of interest in relation to this manuscript. Other editorial staff involved in making editorial decisions should inform the editors of their current interest, and if there is a conflict of interest, the editorial staff should recuse themselves from making editorial decisions on the manuscript (as they can influence editorial decisions).

The editorial staff should not use the information obtained during the work on manuscripts for personal purposes.

The Editor-in-Chief, Deputy Editors-in-Chief, and Editorial Board members should indicate their affiliation with the journal in their submissions to Regulatory Research and Medicine Evaluation.

If an undisclosed conflict of interest is discovered in an unpublished manuscript, the editorial staff will follow the applicable COPE recommendations.

If an undisclosed conflict of interest becomes clear after publication, the editorial staff of the journal will follow the applicable COPE recommendations.

 

Borrowings and Plagiarism

Regulatory Research and Medicine Evaluation use native Russian-language plagiarism detection software Antiplagiat to screen the submissions. If plagiarism is detected, the COPE guidelines on plagiarism will be followed.

 

Post-publication Discussions and Corrections

In some cases, it may be necessary to change a published article. At Regulatory Research and Medicine Evaluation, the editors support the practice of making necessary amendments to published materials and follow the COPE guidelines.

All the necessary post-publication changes will be followed by a notice, which will always include a reference and link to the original version of the article so that readers can be aware of any changes. At Regulatory Research and Medicine Evaluation, the editors use Expressions of Concern, Corrections, and Retractions. These practices aim to ensure the integrity of published research.

All the expression-of-concern, correction, and retraction notices are made publicly available.

Updates and post-publication discussions

Supplements to a published article

The authors may need to supplement their article after its publication. In this case, a supplement may be published. At Regulatory Research and Medicine Evaluation, all supplements to articles are subject to checks by the editors and may be sent out for peer review.

When an article is supplemented, the editors update the file containing the original version of the article. They publish a notice about the supplement in the next issue of the journal, including information about the article and its authors, a summary of changes, a reference and link to the article.

Commentaries on a published article

A commentary is a short material that expresses an opinion or observation concerning a published article. It is sent to the peer reviewers and authors of the article so that they can prepare a response.

The authors’ response is also sent to the peer reviewers. The commentator is given an opportunity to reply to the authors once, after which they may continue their correspondence in private.

The decision to publish a commentary is made by the editors. The commentary, replies, and rejoinders are then linked to the original version of the article in question.

What should the authors do if they find an error in their article?

The authors may discover a technical or fundamental error after their article has been published. In this case, they should inform the editorial staff of the journal of this error as soon as possible, especially if it may affect the interpretation of the study results or cast doubt on the validity of published information. The contact author is responsible for reaching an agreement within the author team on further communication with the editorial staff.

If you feel that a published article needs to be amended, please contact us by e-mail at vedomosti@expmed.ru.

Article amendment procedure

Corrections

Corrections are made to an article when it is necessary to add missing information or correct an error, and the changes do not affect the scholarly integrity or the original findings.

Examples of possible corrections include amending a figure caption, adding data on research funding, or clarifying information on conflicts of interest.

If such corrections are made, the journal publishes a special correction notice. The general procedure is as follows:

  • A correction is made to the original version of the article.
  • The Crossmark record is updated.
  • A description of the change is entered in the Abstract field of the original version of the article.
  • A correction notice is published, providing information about the original version of the article, a reference and link to the article, the authors’ names, and a summary of the corrections.

The editors do not publish individual notices when correcting spelling mistakes, typos, and other minor issues. In such cases, the site will state that corrections have been made to the article (without further detail).

Expressions of doubt

Regulatory Research and Medicine Evaluation, the editorial staff report an expression of doubt in the following case:

  • Serious concerns have been raised about a published article, but these concerns have not been proven through investigation yet.
  • For some reason, the investigation will not or cannot be completed for a long time.

In this case, readers should be notified as soon as possible.

Once the investigation is completed, the article may be amended or retracted.

Removals

At Regulatory Research and Medicine Evaluation, a removal takes place only in extreme cases where it is not possible to follow the correction, retraction, or expression-of-doubt procedures.

An article may be removed in the following cases:

  • Its dissemination may pose a serious risk;
  • It includes content that violates a research participant’s right to privacy;
  • It violates someone’s legal rights;
  • It is subject to removal by court order.

Retraction (withdrawal) policy

At Regulatory Research and Medicine Evaluation, articles are retracted in the following cases:

  • There is clear evidence that the results are unreliable for a number of reasons, including serious errors in calculations, fabricated data, image manipulation, etc.
  • Plagiarism has been found in the article.
  • The results have already been published earlier in other journals, and the author has not justified the need for re-publication and has not informed the editors of the previous publication.
  • The article uses materials and data without permission.
  • Copyright has been violated, the list of authors includes individuals who do not fulfil the criteria for authorship, or there is another serious legal issue (e.g. breach of confidentiality).
  • The integrity of research has been breached.
  • The peer-review process has been compromised.
  • The author did not disclose a conflict of interest that, in the opinion of the editors, may have influenced the decision of the peer reviewers or editors to publish the article.

At Regulatory Research and Medicine Evaluation, we adhere to the following retraction procedure:

  • The editors investigate the case and make sure that the article needs to be retracted.
  • The editors prepare a retraction notice with the note “Retraction” and the title of the article in question. They describe the reason for the retraction, specify the retraction initiator, and provide a reference and link to the article being retracted.
  • The editors publish the retraction notice.
  • The editors replace the original version of the withdrawn article, noting the fact of withdrawal in the pdf-file.
  • They report the retraction to databases.
  • They transfer information about the withdrawal to the database for retracted articles.

At Regulatory Research and Medicine Evaluation, we work with article retractions according to the COPE guidelines.

Retraction procedure

The retraction procedure follows the guidelines of the Council of Scientific Publication Ethics of the Association of Science Editors and Publishers (ASEP).

  1. If an author/group of authors finds it necessary to withdraw an article, they inform the editorial staff and explain the reason for their decision.
  2. If the Editorial Board decides to withdraw the text based on the results of its evaluation or the information received, the Executive Secretary will inform the author/group of authors about this decision. The author (or the corresponding author if there is a group of authors) will be informed of the retraction reasons.
  3. If the author/group of authors ignores the request of the editorial staff, the Editor-in-Chief or Executive Secretary will request the assistance of the ASEP’s Council of Scientific Publication Ethics.
  4. Having made a decision to retract an article, the editorial staff indicates the reasons for the retraction (if plagiarism is detected, the sources of borrowing should be provided) and the retraction date. The article and its description are not removed from the respective issue on the journal’s website, but a “RETRACTED” watermark and the date of retraction are added to the electronic version of the text; the same information is included in the contents of the issue.
  5. The ASEP’s Council of Scientific Publication Ethics, the scientific information databases (eLIBRARY.RU, CyberLeninka, etc.), and all the network libraries and databases where the journal is indexed are provided with the Editorial Board meeting minutes including the date of the meeting, a list of the board members who attended the meeting, the results of investigation, a reasoned decision, and a form filled in with the following information:

– full name(s) of the author(s) and the title of the article;

– the title of the journal from which the text is retracted;

– the initiator of the retraction;

– grounds for the retraction and the decision date;

– a link to the journal’s webpage informing about the retraction;

– the publisher’s data on the article and its DOI (if available);

– the subject area (medicine, pharmaceutics, etc.);

– the editorial policy revision date.

 

Preprint and Postprint Deposition

At Regulatory Research and Medicine Evaluation, the authors are allowed to post their manuscripts as preprints before submission to the journal and also to archive their articles in disciplinary and institutional repositories at their own discretion.

Preprints

At Regulatory Research and Medicine Evaluation, we encourage uploading preprints to preprint servers. The Committee on Publication Ethics (COPE) defines a preprint as “a scholarly manuscript posted by the author(s) in an openly accessible platform, usually before or in parallel with the peer review process”.

A preprint publication is not considered a duplicate publication in a way that would influence the decision to publish it in Regulatory Research and Medicine Evaluation.

When submitting a manuscript to Regulatory Research and Medicine Evaluation, the authors should notify the editorial staff of the journal of having posted the manuscript as a preprint, link to the preprint providing its DOI, and specify the dissemination policy.

It is the authors’ responsibility to link to the published article in the preprint record. The link must contain the DOI and URL of the article published on the journal’s website. The original content of the preprint should not be changed based on the reviewers’ and editors’ comments, nor should the preprint be replaced with the text of the published article. The preprint text should not be deleted.

Manuscripts accepted for publication

At Regulatory Research and Medicine Evaluation, the authors are allowed to archive their reviewed and accepted manuscripts at their own discretion.

A reviewed and accepted manuscript may be disseminated through:

  • a personal website or blog;
  • an institutional repository;
  • a discipline-specific repository;
  • direct interactions with faculty members or students by providing them with the reviewed and accepted manuscript for personal use.

The text of the manuscript should contain the authors’ clarifications about its status and information about its planned publication.

For example: “The article ‘Title of the Article’ has completed peer review and is accepted for publication in issue 3, 2021, of the journal Regulatory Research and Medicine Evaluation.

Upon publication of the final version of the manuscript, the authors should provide a link to the published article in the previous publication record. The original text of the previously published version of the manuscript should not be changed based on the reviewers’ and editors’ comments, nor should the previously published version be replaced with the text of the published article. The text of the previously published version should not be deleted.

Final versions of manuscripts

At Regulatory Research and Medicine Evaluation, the authors are allowed to archive their manuscripts that have been reviewed, accepted for publication, and passed editorial processing (proofreading and pagination), at their own discretion.

This version of the manuscript may be disseminated through:

  • A personal website or blog;
  • An institutional repository;
  • A discipline-specific repository;
  • Direct interactions with faculty members or students by providing them with the final version of the manuscript for personal use

Upon publication of the final version of the manuscript, the authors should provide a link to the published article in the previous publication record. The original text of the previously published version of the manuscript should not be modified based on the reviewers’ and editors’ comments, nor should the previously published version be replaced with the text of the published article. The text of the previously published version should not be deleted.

 

Data Recycling and Reproduction

This section on the journal policies is based on the COPE recommendations for data management.

The authors are encouraged to make research data supporting their publications publicly available, but they are not obliged to do so. The authors’ consent to grant open access to the research data will not impact the editorial decision on publishing the article.

Definition of research data

Research data include any factual materials which were used in the research, recorded on any media, in a digital or non-digital form. These include tabular data, codes, images, audio- and video files, documents, maps, raw and/or processed data. This policy applies to the research data that may be required to verify the study results reported in articles published in Regulatory Research and Medicine Evaluation. Research data include information obtained directly by the authors (“primary data”) and data from other sources analysed by the authors in their study (“secondary data”).

Definition of exceptions

This policy does not apply to research data that are not required to verify the validity of the research results reported in published articles.

Information on confidential data may be shared via publishing in research data repositories with limited access or pre-anonymisation. The authors can also grant open access only to the research metadata and/or instructions for other researchers on requesting access to the data.

Storage of data

The preferred mechanism for sharing research data is via data repositories. Please see https://repositoryfinder.datacite.org or https://www.openrepository.ru to find research data repositories.

Data citation

At Regulatory Research and Medicine Evaluation, the editorial staff encourage the provision of access to research data under the Creative Commons open-copyright licences. The editorial staff do not enforce the use of open-copyright licences when data are deposited in a third-party repository. The Publisher of the journal does not claim ownership of the research data which were provided by the authors with the article.

Questions regarding the implementation of this policy may be addressed to the Executive Secretary of Regulatory Research and Medicine Evaluation.

 

Animal Welfare and Human Rights

Human rights clause

The journal Regulatory Research and Medicine Evaluation relies on the principles of the Declaration of Helsinki of the World Medical Association (Ethical Principles for Medical Research Involving Human Subjects) and endeavours to ensure compliance with ethical and data collection standards for research involving human subjects. Before beginning research, the researchers should familiarise themselves with the principles of the Helsinki Declaration on informed consent, and carry out the research in strict accordance with those principles as set forth below (Articles 25‒32 of the Helsinki Declaration):

“25. Participation by individuals capable of giving informed consent as subjects in medical research must be voluntary. Although, it may be appropriate to consult family members or community leaders, no individual capable of giving informed consent may be enrolled in a research study unless he/she freely agrees.

26. In medical research involving human subjects capable of giving informed consent, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, post-study provisions and any other relevant aspects of the study. The potential subject must be informed of his right to refuse to participate in the study or to withdraw his consent to participate at any time without reprisal. Special attention should be given to the specific information needs of individual potential subjects as well as the methods used to deliver the information.

After ensuring that the potential subject has understood the information, the physician or another appropriately qualified individual must then seek the potential subject's freely-given informed consent, preferably in writing. If the consent cannot be expressed in writing, verbal consent must be formally documented and witnessed.

All medical subjects should be given the option of being informed about the general outcome and results of the study.

27. When seeking informed consent for participation in a research study, the physician must be particularly cautious when the potential subject is in a dependent relationship with the physician or may consent under duress. In such situations, the informed consent must be sought by an appropriately qualified individual who is completely independent of this relationship.

28. For a potential research subject who is incapable of giving informed consent, the physician must seek informed consent from his legally authorised representative. These individuals must not be included in a research study that has no likelihood of benefit for them unless it is intended to promote the health of the group represented by the potential subject, the research cannot instead be performed with persons capable of providing informed consent, and the research entails minimal risk and burden.

29. When a potential research subject who is deemed incapable of giving informed consent is able to give assent to decisions about participation in research, the physician must seek that assent in addition to the consent of the legally authorised representative. The potential subject's dissent should be respected.

30. Research involving subjects who are physically or mentally incapable of giving consent, for example, unconscious patients, may be done only if the physical or mental condition that prevents giving informed consent is a necessary characteristic of the research group. In such circumstances the physician must seek informed consent from the legally authorised representative. If no such representative is available and if the research cannot be delayed, the study may proceed without informed consent provided that the specific reasons for involving subjects with a condition that renders them unable to give informed consent have been stated in the research protocol and the study has been approved by a research ethics committee. Consent to remain in the research must be obtained as soon as possible from the subject or a legally authorised representative.

31. The physician must fully inform the patient which aspects of their care are related to the research. The refusal of a patient to participate in a study or the patient's decision to withdraw from the study should never adversely affect the patient-physician relationship.

32. For medical research using identifiable human material or data, such as research on material or data contained in biobanks or similar repositories, physicians must seek informed consent for its collection, storage and/or reuse. There may be exceptions where consent would be impossible or impractical to obtain for such research. In such situations, the research may be done only after consideration and approval of a research ethics committee”.

When presenting the results of experimental studies with humans, the Authors should indicate in the corresponding section of the article whether the procedures performed met the ethical standards described in the Helsinki Declaration. If the study was conducted without regard to the principles of the Declaration, the authors should justify the approach chosen for the study and provide evidence that the Ethics Committee of the organisation where the study was conducted endorsed the chosen approach.

Animal welfare regulation

The Regulatory Research and Medicine Evaluation places emphasis on compliance with animal welfare norms and principles in laboratory animal experiments.  

Manuscripts will be considered for publication only if the work detailed therein:

1) follows international, national, and/or institutional guidelines for humane animal treatment and complies with relevant legislation (European Convention for the Protection of Vertebrate Animals used for Experimental and Other Scientific Purposes, Directive 2010/63/EU of the European Parliament and of the Council, Consensus Author Guidelines for Animal Use, GOST 33215-2014. Guidelines for accommodation and care of animals. Environment, housing and management);

2) has been approved by the ethics review committee at the institution at which the studies were conducted where such a committee exists.

Animal ethics-based criteria for manuscript rejection:

1) manuscripts and authors that fail to meet the aforementioned requirements;

2) studies that involve unnecessary pain, distress, suffering, or lasting harm to animals;

3) the Editorial staff retains the right to reject manuscripts on the basis of ethical or welfare concerns.

 

Advertising

For Regulatory Research and Medicine Evaluation, advertising is not a stream of revenue.

The journal does not accept manuscripts with commercial content, including covert advertising, and does not publish such articles.

 

Crossmark policy

CrossMark is a multi-publisher initiative from Crossref, provides a standard way for readers to locate the authoritative version of an article or other published content. By applying the CrossMark logo, journal Regulatory Research and Medicine Evaluation  is committing to maintaining the content it publishes and to alerting readers to changes if and when they occur.

Clicking the CrossMark logo on a document will tell you its current status and may also give you additional publication-record information about the document.

 

 

 

Retraction

The Editorial Board of the journal Regulatory Research and Medicine Evaluation would like to extend their sincere apologies for any inconvenience this retraction may have caused.

 

Retracted article: Ryazhenov V.V., Gorokhova S.G., Bunyatyan N.D. Opportunities of the method «budget impact analysis» for performing pharmacoeconomic research. Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2011;(1):56–9 (In Russ.).

This article has been withdrawn (retracted) by the editorial staff of the journal Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. Regulatory Research and Medicine Evaluation as a duplicate of Ryazhenov V.V., Gorokhova S.G., Bunyatyan N.D. Budget impact analysis: the specific features of using the method. Farmatsiya. 2011;(1):41–4 (In Russ.).

Editorial Board Minutes No. 2 of June 7, 2022.

 

Retracted article: Mironov A.N., Sakaeva I.V., Dudchenko V.V., Korneeva L.V., Yavorsky A.N. International experience in drug names assessment: European Medicines Agency. Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2013;(2):38–42 (In Russ.).

This article has been withdrawn (retracted) by the editorial staff of the journal Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. Regulatory Research and Medicine Evaluation as a duplicate of Gerasimov V.B., Yagudina R.I., Gracheva Yu.V., Dudchenko V.V., Yavorsky A.N. Recommendations of the European Union on the rational choice of newly formed drug names. Remedium. 2006;(5):32–5 (In Russ.).

Editorial Board Minutes No. 2 of June 7, 2022.

 

Retracted article: Sakanyan E.I., Bunyatyan N.D., Lyakina M.N., Tereshina N.S., Shemeryankina T.B., Postoyuk N.A. Dosage forms and their role in modern homeopathic practice. Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2014;(2):60–3 (In Russ.).

This article has been withdrawn (retracted) by the editorial staff of the journal Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. Regulatory Research and Medicine Evaluation as a duplicate of Lyakina M.N., Sakanyan E.I., Shemeryankina T.B., Postoyuk N.A. To the issue of harmonization of requirements to be included in the quality standards for homeopathic medicines. Jounal of pharmaceuticals quality assurance issue. 2013;(2):30–6 (In Russ.).

Editorial Board Minutes No. 2 of June 7, 2022.

 

Retracted article: Yakushev V.I., Pokrovsky M.V., Beskhmelnitsyna E.A., Myasishcheva O.V., Litvinova A.S., Krivoshapova I.I., Demchenko S.A. Arginase II – a new target in the development of endothelium protectors. Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2015;(1):26–30 (In Russ.).

This article has been withdrawn (retracted) by the editorial staff of the journal Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. Regulatory Research and Medicine Evaluation as a duplicate of Yakushev V.I., Pokrovsky M.V., Korokin M.V., Pokrovskaya T.G., Kulikovskaya V.A., Ershov I.N., Beshmelnitsyna E.A., Arustamova A.A., Kotelnikova L.V. Arginase is a new target for pharmacological correction of the endothelial dysfunction. Belgorod State University Bulletin Medicine Pharmacy. 2012;(22–3):36–40 (In Russ.).

Editorial Board Minutes No. 2 of June 7, 2022.

 

Retracted article: Zhuravleva M.V., Kukes V.G., Prokofiev A.B., Arkhipov V.V., Olefir Yu.V., Serebrova S.Yu., Sokolov A.V., Sychev D.A. Efficacy and safety of medicines: the value and opportunities of clinical pharmacology. Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2015;(2):20–24 (In Russ.).

This article has been withdrawn (retracted) by the editorial staff of the journal Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. Regulatory Research and Medicine Evaluation as a duplicate of Kukes V.G., Zhuravlyova M.V., Sychyov D.A. Efficacy and safety of medicinal products: role of clinical pharmacology service. Doctor.Ru. 2014;(S3):23–30 (In Russ.).

Editorial Board Minutes No. 2 of June 7, 2022.

 

On the use of AI-assisted technologies

Using AI tools

Due to the wide use AI in preparing, writing and peer-reviewing research papers the editorial team of the journal “Regulatory Research and Medicine Evaluation” is committed to ensure that such use aligns with our publishing requirements and ethical standards  to meet the following provisions.

  1. Responsibility and authorship
  • Responsibility for the content of the manuscript, including the accuracy of data, correct citation and compliance with ethical standards, lies entirely with the authors, regardless of their use of generative AI tools (i.e., capable of creating new content). The authors guarantee that the final text of the manuscript is original, reflects the results of the research conducted by the authors.
  • AI (chatbots, such as ChatGPT and similar tools) cannot be listed as authors of the article or as persons who contributed to the preparation of the manuscript. AI-based programs do not meet the criteria for authorship, as they are not liable for the content of the work, cannot declare conflicts of interest, or manage copyright.
  1. Human oversight and validity
  • When using AI tools as aids for text editing, literature search, data analysis and visualization, or idea generation, users are required to ensure human control at all stages of manuscript preparation, carefully checking all AI-generated outputs, including facts, citations, and analytical conclusions, for compliance with the relevance of the research data and accepted scientific standards.
  • It is allowed to use AI to generate images (diagrams) illustrating processes, concepts, and mechanisms of action. It is prohibited to use AI to generate actual research results or modify images obtained during the study.
  1. Transparency and disclosure
  • Authors are required to indicate the use of generative AI tools when submitting a manuscript, including: the name and version of the AI tool; purpose of use (e.g. text mining/ editing, data analysis, generating processes flowcharts described in the work, used questionnaires, manuscript abstracts, etc.); prompts used in generative AI.
  • Authors may not provide this information if non-generative AI was used or if generative AI did not significantly modify the content of the manuscript, for example:
  • basic grammar checking;
  • replacing only a few words in the text without changing the contextual meaning;
  • a general literature search using AI without its interpretation and data synthesis;
  • literature sources formatting without recommending/generating sources;
  • general editing of images without their modification (cropping, increasing contrast, etc.).
  • The editors may request additional information about the use of AI to ensure transparency and compliance with ethical standards.
  1. Rights and privacy protection
  • Authors and reviewers must ensure that the AI ​​tools used:
  • comply with the requirements for the protection of personal/ sensible data and confidentiality;
  • do not violate the rights of third parties, including intellectual property and data privacy;
  • do not gain the rights to content created by authors and do not use it to train AI models without the user's consent.
  • By submitting material created using AI, authors guarantee that they have the right to use the generative content under the terms of the AI ​​licenses.
  1. Technical control by the editors
  • The Journal uses specialized tools such as national industry leader Antiplagiat plagiarism checker to identify texts generated by AI. Manuscripts containing unjustified use of AI may be rejected or sent for revision.
  1. Compliance with international standards and best practices

The editorial team of the journal "Regulatory Research and Medicine Evaluation" supports the provisions of Russian regulations, the position of the international publishing community and best practices presented in the following documents:

  • Russian GOST 71657-2024 about the use of AI tools in writing scientific publications
  • World Association of Medical Editors (WAME) – Chatbots, Generative AI, and Scholarly Manuscripts
  • International Committee of Medical Journal Editors (ICMJE) – Recommendations, Part II, paragraph A4
  • Editorial policy of Wiley and Springer Nature regarding the principles of using AI in scientific publications

Editorial policy — Updated 14 April 2025



Publisher: Scientific Centre for Expert Evaluation of Medicinal Products

Processing of personal data
Development and technical support
of the site is carried out by NEICON
(Elpub lab)